Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (8/28/24) through T+5. Run-up high $30.19 on 10/16/24, low $24.8 on 11/22/24 (T-120 to T-1). FDA decision 2/12/25. Historical price action, not a forecast.
Positioning before the decision
On Jan 29, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.9% through Feb 14, 2025 (the first listed expiry after the decision; ATM implied volatility 29%). The stock closed -0.2% at the first close across the decision and +1.4% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.
Decision facts
FDA decision date2025-02-12
DrugADCETRIS (brentuximab vedotin) with lenalidomide and rituximab - (ECHELON-3)
IndicationRelapsed/refractory diffuse large B-cell lymphoma (DLBCL)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was ADCETRIS (brentuximab vedotin) approved by the FDA?
Yes. The FDA approved the application for ADCETRIS (brentuximab vedotin) on February 11, 2025, per the FDA's own record. The company announced it on February 12, 2025. The primary source is linked on this page.
What was ADCETRIS (brentuximab vedotin) under FDA review for?
The application covered Relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The FDA approved the application on February 12, 2025.
How did PFE stock react to the FDA decision?
On the decision day PFE moved -0.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.